Provide expert guidance on global regulatory requirements and submission processes

Support regulatory strategy, submission planning, compliance management, and regulatory intelligence initiatives

Collaborate with business stakeholders, regulatory affairs teams, quality teams, IT teams, and external partners

Support preparation, review, and submission of regulatory dossiers

Guide teams on submission planning, document requirements, and approval workflows

Monitor emerging regulations and industry trends

Analyze regulatory changes and assess business impact

Participate in audits, inspections, and compliance assessments

Act as business SME for Regulatory Information Management (RIM) systems

Define business requirements and review solution design